Gardasil could protect older women against HPV

A new study shows that Sanofi Pasteur MSD's human papilloma virus (HPV) vaccine - Gardasil - protects women up to the age of 45, boosting hopes that, one day, older women may be able to get the vaccine. 

This is the first time that a cervical cancer vaccine has been shown to prevent HPV-related diseases in older women. 

The study showed that Gardasil prevented 92 per cent of HPV types 6, 11, 16 and 18-related genital diseases (including early and pre-cancerous cervical lesions, pre-cancerous vulvar and vaginal lesions, and genital warts) in women aged 24 to 45, prior to exposure to the relevant virus types.

"Women remain at significant risk for developing HPV-related genital diseases, including cervical cancer, throughout their lifetime," said Patrick Poirot, vice president for medical and scientific affairs at Sanofi Pasteur MSD. 

"These new results suggest that Gardasil has comparable efficacy in older women to that shown in girls and young women and that older women could also benefit from this vaccine,î he continued.

Most European countries have adopted, or are in the process of implementing, HPV vaccination programmes for 11-18 year olds; no country has anything in place for the vaccination of older women. 

"Based on these encouraging new results, the competent regulatory bodies and experts will now have to define how to approach the possible vaccination of older women in the future," stated Poirot. 

"Until this is done, the focus of public health authorities will certainly remain on vaccinating girls and young women prior to exposure to HPV,î he concluded. 

Merck (who co-markets the vaccine with Sanofi Pasteur MSD) plans to submit the new data to the US Food and Drug Administration (FDA) by the end of 2007 to get approval to market Gardasil to women up to the age of 45. 

The study

The study included 3,819 women aged 24 to 45 from the Americas, Europe and Asia, who were enrolled in a 1:1 ration randomised, double-blind study. 

The women had no history of LEEP (loop electrosurgical excision procedure) or hysterectomy; no history of biopsy-diagnosed cervical human papillomavirus disease in the past five years and no history of genital warts. Pap testing and cervico-vaginal sampling was performed at six-month intervals for a total of 48 months. 

Analyses were conducted among subjects PCR- and seronegative to the relevant HPV type (6, 11, 16, 18). 

Subjects received three doses of either Gardasil or a placebo at day 1, month 2 and month 6. Analysis was done in a per-protocol efficacy population through a mean follow up of 1.65 years after start of vaccination. 

The first co-primary endpoint was combined incidence of persistent infection (same virus type found at six months interval), early or pre-cancerous cervical lesions (all grades of CIN), as well as external genital lesions (EGLs: vulvar and vaginal precancerous lesions, genital warts) caused by HPV types 6, 11, 16, 18.

Efficacy was 91 per cent (95 per cent CI [74, 98]). In order to evaluate the efficacy against clinical disease alone (early or pre-cancerous cervical lesions [all grades of CIN], as well as EGLs), persistent infection was extracted from the first co-primary endpoint. Efficacy against clinical disease alone was 92 per cent (95 per cent CI [50,100]) as reported above.

The data was presented at the 24th International Papillomavirus Conference (IPC) in Beijing, China, on 5th November 2007.